Drug & medication recalls Moderate risk

Amneal Pharmaceuticals of New York, LLC recalls Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewate…

Recall date
October 27, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0090-2024
FDA classification
Class II
Brand / firm
Amneal Pharmaceuticals of New York, LLC
Sold / distributed
Nationwide in the USA and Puerto Rico

Why it was recalled

Failed Dissolution Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10

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